Debio 4228 for Prostate Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on androgen deprivation therapy or have used exogenous testosterone recently, you may not be eligible. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the drug Debio 4228 for prostate cancer?
What is the purpose of this trial?
The primary purpose of this study is to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of Debio 4228.
Eligibility Criteria
This trial is for men with advanced or metastatic prostate cancer who are candidates for ongoing hormone therapy. They should have a life expectancy of at least 6 months, be relatively active (ECOG status 0-2), and have normal organ function. Specific medical criteria must also be met.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intramuscular (IM) administration of Debio 4228 on Day 1
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants in Cohort 3 may receive a maintenance dose 12 weeks after the initial dose
Treatment Details
Interventions
- Debio 4228
Find a Clinic Near You
Who Is Running the Clinical Trial?
Debiopharm International SA
Lead Sponsor